GS from recent conference presentation:
Stock rating: In-Line
Coverage view: Neutral
Small-Cap Growth
Price: US$12.28
June 11, 2003
At the 24th Goldman Sachs Global Healthcare Conference today, management reviewed
the company's pipeline. Abgenix, and partner Amgen, have five ongoing clinical trials
with ABX-EGF for the potential treatment of cancer. The company recently presented
encouraging Phase II data at ASCO in patients with colon cancer. We look for additional
Phase II data going forward. Abgenix also provided top line detail on its pipeline of over
30 candidates spanning oncology (2/3 of focus), inflammation, cardiovascular &
infectious diseases as well as manufacturing progress. Maintain IL rating and Neutral
coverage view.
INVESTMENT OUTLOOK: We believe that Abgenix represents an attractive
opportunity for long term oriented investors with a high risk tolerance. Abgenix is
distinguished by its ability to make fully human antibodies to a broad range of targets, a
platform technology that can fuel an expansive, diversified pipeline. Abgenix has
established a blue chip partner list and has the potential to develop a growing roster of
proprietary therapeutic antibodies. Over the next several years, we expect a range of new
antibodies to enter the clinic on a proprietary and partnered basis.
I. ABX-EGF
ABX-EGF is a fully human antibody to the EGF receptor, which is over- expressed in a
range of cancers. Abgenix and partner Amgen, are developing ABX-EGF in a number of different
oncology applications. A series of Phase II studies are underway in renal, colorectal, prostate cancer
and non-small cell lung cancer.
** Interim colorectal cancer data presented at ASCO **
Data were reported from an interim analysis of one of two open-label trials with ABX-EGF ongoing
in colorectal cancer. Although a relatively small study, we regard the data as encouraging so far.
This study includes patients who are refractory to chemotherapy, including the Saltz regimen. Some
patients were also refractory to oxaliplatin. Data were reported on 40 patients evaluable for efficacy
(having had at least 5 EGF doses) and on 44 patients on an intent to treat basis. The study will
include 150 patients (expanded from 100 to get more data on oxaliplatin treated patients) who will
receive monotherapy intravenous infusions of 2.5 mg/kg of ABX-EGF weekly over an 8-week
treatment cycle, for up to 6 cycles. The endpoints of the trial are tumor response rates and time to
progression.
** Other EGF studies underway **
In the second trial in colorectal cancer, initiated in January 2002, up to 84 patients will receive
weekly intravenous infusions of 2.5 mg/kg of ABX- EGF in combination with standard doses of
irinotecan, leucovorin, and 5- fluorouracil (Saltz regiment) over a 6-week treatment cycle, for up to
eight cycles.
** prostate cancer **
In January 2002, Abgenix initiated a 50-patient, multi-center, open-label Phase II study of
ABX-EGF in prostate cancer patients who are failing hormone replacement therapy. In this trial,
patients will receive intravenous infusions of 2.5 mg/kg of ABX-EGF weekly over an 8-week
treatment cycle, for up to 5 cycles. The primary efficacy endpoint of the study will be measured by
prostate specific antigen (PSA) response rates (decrease of PSA level by >50% compared to
baseline). This study is intended to be a proof of principle study as PSA levels are not an accepted
primary endpoint.
** renal cancer **
Positive initial Phase II data on ABX-EGF as monotherapy in 88 advanced kidney cancer patients
were reported at ASCO in May, 2002. At 8 weeks, stable disease was achieved in 50% of the
patients. We believe this is a strong start given the severity of the patients studied, and the fact that
ABX-EGF was studied as monotherapy. The second part of this study will assess less heavily
treated pretreated patients and has enrolled 115 new patients.
Following the recent approval of AstraZeneca's Iressa as well as positive data on Bristol
Myers/Imclone's Erbitux, there is growing enthusiasm for the EGF class. We believe that Abgenix
and Amgen will be aggressive in the development of ABX-EGF, however it is not yet clear what
the next studies for potential approval will be. We believe additional data from ongoing Phase II
studies will facilitate the process.
II. MANUFACTURING
Abgenix has completed construction of its manufacturing facility, which is capable of producing
200-400 Kg of material annually. State inspection is expected shortly. Given the typically high
production requirements for antibody therapeutics, we regard the facility as a strategic asset.
I, Meg Malloy, ... |
